What you need to know

Through the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership, NIH is prioritizing therapeutic agents for clinical trials to develop new and better treatments for COVID-19. The ACTIV-1 Immune Modulators (IM) trial is a study to find out whether a type of medicine known as an immune modulator can help COVID-19 patients who have an overwhelming immune response.

What is this research about?

Some COVID-19 patients experience a “cytokine storm.” A cytokine storm is a strong immune response that releases excessive amounts of proteins that trigger inflammation. This immune response can lead to life-threatening complications such as acute respiratory distress syndrome and multiple organ failure.

How does the study work?

All participants in the trial receive the standard treatment for hospitalized patients with COVID-19. In addition to that treatment, they receive either a placebo or one of three immune modulators (cenicriviroc, abatacept, and infliximab). The clinical trial aims to determine whether modulating the immune response can reduce the need for ventilators and shorten hospital stays.

The Phase 3 trial started in October 2020 and is expected to last approximately six months.

Who is included?

The researchers plan to enroll approximately 2,100 adults in the United States and Latin America who are hospitalized with moderate to severe COVID-19.

Why is this research important?

This research has the potential to identify a lifesaving treatment for people with COVID-19.

Where can I go to learn more?

NIH Press Release: NIH begins large clinical trial to test immune modulators for treatment of COVID-19

  • Read more about the launch of this study.

ClinicalTrials.gov: Immune Modulators for Treating COVID-19 (ACTIV-1 IM)

  • ClinicalTrials.gov has information on the trial, including eligibility criteria and contact information for research staff.

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)

  • Learn more about the ACTIV public-private partnership.

Sources

National Institutes of Health. (2020). NIH Press Release: NIH begins large clinical trial to test immune modulators for treatment of COVID-19. Retrieved February 11, 2021, from https://www.nih.gov/news-events/news-releases/nih-begins-large-clinical-trial-test-immune-modulators-treatment-covid-19

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